Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Benzonatate Capsules USP, 100 mg are available as yellow, oval soft gelatin capsules with‘1’imprinted in white ink. Bottles of 100 NDC 64980-634-01 Bottles of 500 NDC 64980-634-50 Benzonatate Capsules USP, 200 mg are available as yellow, oval soft gelatin capsules with‘2’imprinted in white ink. Bottles of 100 NDC 64980-635-01 Bottles of 500 NDC 64980-635-50 Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT; PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label NDC 64980-634-01 Benzonatate Capsules USP 100 mg Rx only 100 CAPSULES Rising Pharma Holdings, Inc. Benzo-cap-100mg; PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Label NDC 64980-635-01 Benzonatate Capsules USP 200 mg Rx only 100 CAPSULES Rising Pharma Holdings, Inc. Benzo-cap-200mg
- HOW SUPPLIED Benzonatate Capsules USP, 100 mg are available as yellow, oval soft gelatin capsules with‘1’imprinted in white ink. Bottles of 100 NDC 64980-634-01 Bottles of 500 NDC 64980-634-50 Benzonatate Capsules USP, 200 mg are available as yellow, oval soft gelatin capsules with‘2’imprinted in white ink. Bottles of 100 NDC 64980-635-01 Bottles of 500 NDC 64980-635-50 Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT
- PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label NDC 64980-634-01 Benzonatate Capsules USP 100 mg Rx only 100 CAPSULES Rising Pharma Holdings, Inc. Benzo-cap-100mg
- PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Label NDC 64980-635-01 Benzonatate Capsules USP 200 mg Rx only 100 CAPSULES Rising Pharma Holdings, Inc. Benzo-cap-200mg
Overview
Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsule USP,100 mg contains: Benzonatate, USP 100 mg. Each benzonatate capsule USP,200 mg contains: Benzonatate, USP 200 mg. Benzonatate Capsules USP also contain: D&C Yellow 10, gelatin, glycerin, methylparaben, propylparaben, shellac and titanium dioxide. Chemical Structure
Indications & Usage
Benzonatate Capsule is indicated for the symptomatic relief of cough.
Dosage & Administration
Adults and Children over 10 years of age Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate Capsules should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.
Warnings & Precautions
WARNINGS Hypersensitivity Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures. Psychiatric Effects Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking Benzonatate Capsule in combination with other prescribed drugs. Accidental Ingestion and Death in Children Keep Benzonatate Capsules out of reach of children. Accidental ingestion of Benzonatate Capsules resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE ).
Contraindications
Hypersensitivity to benzonatate or related compounds.
Adverse Reactions
Potential Adverse Reactions to Benzonatate Capsules may include: Hypersensitivity reactions including bronchospasm, laryngospasm,cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule. CNS: sedation; headache; dizziness; mental confusion; visual hallucinations. GI: constipation; nausea; GI upset. Dermatologic: pruritus; skin eruptions. Other: nasal congestion; sensation of burning in the eyes; vague "chilly" sensation; numbness of the chest; hypersensitivity. Deliberate or accidental overdose has resulted in death, particularly in children.
Storage & Handling
Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT
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